Ketoconazole

Ketoconazole in plain language

What it is

Also known as (+/-)-Ketoconazole · Brizoral · Extina · Fungarest · Fungoral · J02AB02

Show all 12 names

Ketozole · Nizoral · R 41,400 · R-41400 · Xolegel · ketoconazole (1-2 % w/w)

What it does

Ketoconazole is the heterocyclic compound.

• Anti-dandruff

Is it a concern?

Critical concern: classified for carcinogenic, mutagenic or reproductive toxicity (CMR). It is banned in EU cosmetics.

Why it's flagged

• Cmr

Ketoconazole; 1-[4-[4-[[(2SR,4RS)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone is prohibited in cosmetic products under Annex II of the EU Cosmetics Regulation (EC) 1223/2009.

RestrictedEU EC — banned

The score describes this ingredient's chemical identity — its hazard profile from published classifications and regulatory status — not the safety of any product it appears in.

• EU Annex II — prohibited
• EU prohibited in cosmetics

• EU·EC

  Annex II of EU Cosmetics Regulation (EC) 1223/2009: substances prohibited in cosmetic products. CMR: Reprotoxic Cat. 1B()

  banned
  View source →

• EU·CosIng·Active2 entries

  • Ketoconazole is the heterocyclic compound that conforms to the formula Restriction: II/1528Source →
  • Cosmetics Regulation annex II / ref 1528.Source →
• US·EPA·commercial use observedEPA CPDat observed this chemical in 7 composition records across product categories including Personal care, Raw materials. EPA CPDat classifies this chemical for functional uses including Anti-dandruff.

  • EPA CPDat observed this chemical in 7 composition records across product categories including Personal care, Raw materials. EPA CPDat classifies this chemical for functional uses including Anti-dandruff.Source →
• US·FDA·listed in openFDA substanceopenFDA substance registry classifies this ingredient as chemical.

  • openFDA substance registry classifies this ingredient as chemical.Source →

Expert safety opinions

No expert opinion on file for Ketoconazole. These are the independent scientific bodies that assess ingredients like this one; we show an opinion only when a record we hold cites it.

• SCCS

  EU Scientific Committee on Consumer Safety

  No SCCS opinion on file.

• CIR

  Cosmetic Ingredient Review (US expert panel)

  No CIR safety assessment on file.